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Royal Decree 579/2017, Of 9 June, Which Regulates Certain Aspects Relating To The Manufacture, Presentation And Sale Of Tobacco Products And Related Products.

Original Language Title: Real Decreto 579/2017, de 9 de junio, por el que se regulan determinados aspectos relativos a la fabricación, presentación y comercialización de los productos del tabaco y los productos relacionados.

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TEXT

I

The Spanish Constitution recognizes in its article 43 the right to health protection, and entrusts to the public authorities the organization and protection of public health through the adoption of preventive measures. consider necessary.

Law 14/1986 of 25 April, General of Health, established the obligation of public health administrations to direct their actions as a priority to the promotion of health and the prevention of diseases, to avoid activities and products which, directly or indirectly, may have negative health consequences and regulate their advertising and commercial propaganda.

Tobacco use represents the main risk factor for disease and mortality in developed countries, so its regulation and control of its consumption should be a priority in public health. The current regulation of tobacco products, from the point of view of public health, is essentially contained in two rules.

On the one hand, Law 28/2005 of 26 December on sanitary measures against smoking and regulating the sale, supply, consumption and advertising of tobacco products, which is the basic general rule of the State on tobacco, from the point of view of public health.

On the other hand, Royal Decree 1079/2002 of 18 October, regulating the maximum levels of nicotine, tar and carbon monoxide of cigarettes, the labelling of tobacco products, as well as measures concerning ingredients and names of tobacco products, which contains in our legal order the content of Directive 2001 /37/EC of 5 June 2001 on the approximation of provisions laid down by law, regulation or Member States ' administrative authorities in the field of manufacturing, presentation and sale of the tobacco products. By Royal Decree 639/2010 of 14 May, Royal Decree 1079/2002 of 18 October 2002 was amended to adapt its content to the provisions of Law 28/2005 of 26 December.

Several Community rules have been adopted subsequently which have shaped a new legal framework for tobacco regulation at European level, which makes it necessary to adapt it to the same legal system.

First, Directive 2014 /40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the manufacture, presentation and sale of tobacco products and related products, and repealing Directive 2001 /37/EC, adopted in order to facilitate the smooth functioning of the internal market in tobacco and products on the basis of a high level of protection of human health, and in the European Union, to meet the obligations under the WHO Framework Convention for Tobacco Control.

Second, Commission Delegated Directive 2014 /109/EU of 10 October 2014 amending Annex II to Directive 2014 /40/EU by establishing the library of graphic warnings to be used in the tobacco products, as well as various implementing decisions that develop various aspects of their content and which can be grouped into three blocks.

On the one hand, decisions related to the location of health warnings, such as Commission Implementing Decision (EU) 2015/1735 of 24 September 2015 on the exact position of the general warning and of the information message on tobacco for liar in petaca, and Commission Implementing Decision (EU) 2015/1842 of 9 October 2015 on the technical specifications for the presentation, design and form of the warnings combined health of tobacco products for smoking.

On the other hand, decisions related to the common electronic format for notifications, such as Commission Implementing Decision (EU) 2015/2183 of 24 November 2015, establishing a common format for the notification of electronic cigarettes and recharging packages, Commission Implementing Decision (EU) 2015/2186 of 25 November 2015 laying down a format for the submission and provision of information on tobacco products, and Commission Implementing Decision (EU) 2016/586 of 14 April 2009 on tobacco products 2016, concerning the technical standards for the mechanism of recharging of electronic cigarettes.

Finally, the decisions and implementing rules concerning ingredients, such as Commission Implementing Decision (EU) 2016/787 of 18 May 2016 establishing a priority list of additives contained in cigarettes and tobacco for the liar subject to reinforced notification obligations, Commission Implementing Regulation (EU) 2016/779 of 18 May 2016 adopting uniform rules on procedures to determine whether a tobacco product has a characteristic flavour and the Implementing Decision (EU) Commission Implementing Regulation (EU) 2016/786 of 18 May 2016 adopting the procedure for the establishment and operation of an independent advisory group assisting the Member States and the Commission in determining whether the products of the tobacco have a characteristic aroma.

Third and last, account should also be taken of the provisions of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures and amending and repealing Directives 67 /548/EEC and 1999 /45/EC and amending Regulation (EC) No 1907/2006.

II

The purpose of this royal decree is the partial transposition of Directive 2014 /40/EU of the European Parliament and of the Council of 3 April 2014 on the manufacture, presentation and marketing of products products of tobacco and related products, including traceability and safety measures for tobacco products, replacing the regulation contained in Royal Decree 1079/2002 of 18 October, which is repealed.

The royal decree regulates certain aspects related to the manufacture and marketing of tobacco products, novel products, nicotine-releasing devices, and recharging containers. Herbal products for smoking. It should be noted that the novel tobacco products and herbal products for smoking are regulated for the first time, from the public health point of view.

The provisions of the aforementioned Directive on the labelling and packaging of tobacco products are also incorporated, such as the obligation to include certain health warnings in all packaging units, as well as in any outer packaging. In addition, the standard develops the enablement provided for in Article 3.7 of Law 28/2005 of December 26, and regulates the contents and components of tobacco products.

The rule also includes the regulation of verification laboratories, as well as the procedure for their authorization.

Finally, the standard creates three new records, such as manufacturers, importers and distributors of nicotine-release devices and refill containers, that of manufacturers, importers and distributors. Herbal products for smoking, and for verification laboratories.

III

The royal decree is structured into five titles, two additional provisions, three transitional provisions, one repealing provision, five final provisions and two annexes.

The preliminary title, "General Provisions", sets out the object of the royal decree, its scope and the definitions of the terms expressed throughout the article.

Title I, "Tobacco Products", consists of three chapters. Chapter I, dedicated to "Ingredients and Emissions", sets the maximum levels of emissions for cigarettes marketed or manufactured in Spain, as well as methods of measurement, and the ingredients of tobacco products.

Chapter II, dedicated to 'Labelling and Packaging', takes account of the new features introduced by the Directive on the labelling and packaging of tobacco products. Requirements on the labelling and packaging of tobacco products are updated by means of the mandatory inclusion of combined health warnings in all packaging units, as well as any outer packaging, of products smoking tobacco, in addition to other warnings of text and information messages. These measures are in line with the WHO Framework Convention on Tobacco Control, ratified by Spain on 30 December 2004, which provides for in Article 11 that health warnings on the labelling of tobacco products, in particular: The form of images or pictograms is an appropriate instrument for reducing the demand for tobacco. In addition, the packaging units for tobacco products are expected to be labelled in a unique and safe manner, and their movements recorded in order to facilitate the monitoring and tracing of these products in the Union. It also provides for the introduction of security measures to facilitate the verification of the authenticity of tobacco products, although in principle only the monitoring and tracing system and the security measures are subject to the introduction of the cigarettes and the tobacco for liar.

Chapter III, dedicated to the "Novel tobacco products and oral tobacco", regulates the pre-marketing communication obligations of the former, which should include the available scientific studies and the market research, and continues to prohibit the marketing in Spain of tobacco for oral use, as already done by Royal Decree 1079/2002 of 18 October, which is now repealed.

Title II, "Susceptible Nicotine-Release Devices and Recharge Containers," is divided into three chapters. Chapter I contains 'Provisions concerning the marketing' of these products. Its regulation, in addition to the incorporation of Community law, is due to its growing importance, due to the recent developments on the market at European level which have made it necessary to include tobacco-related products. The reporting obligations for these products, the tests and the control and verification requirements are regulated.

Chapter II creates and regulates the Registry of Manufacturers, Importers and Distributors of these products, and their operation.

Chapter III is dedicated to the adverse effects of these products, to the actions to be performed and to their monitoring.

In Title III, under the heading "Herbal Products for Smoking", the requirements of these products, such as communication obligations or their labelling, are regulated. In addition, the Registry of Manufacturers, Importers and Distributors of these products is created and regulated, and their operation.

Title IV is dedicated to "Verification and Control" and regulates the annual verification plan, the procedure to authorize verification laboratories and creates a record for the purpose of collecting and ordering information about these.

The rule concludes with two additional provisions, three transitional provisions, one repealing provision, five final provisions and two annexes.

The second final provision amends Decree 2484/1967 of 21 September, approving the text of the Spanish Food Code, to delete paragraph 3.25.80 of Section 8 of Chapter XXV of Part Three of the Spanish Food Code, thus complying with certain specific requirements for components of the smoking paper imposed at European level.

IV

In the process of drawing up this royal decree the reports of the autonomous communities and cities of Ceuta and Melilla have been gathered, and it has been counted with the participation of business and union organizations, societies scientific and social entities that have been consulted in the audience.

In addition, the Spanish Data Protection Agency and the Economic and Social Council have issued their mandatory reports.

This royal decree is of a basic standard and is dictated by the provisions of Article 149.1.16. of the Spanish Constitution and in the development of Articles 24, 25.3 and 40, paragraphs 5 and 6, of Law 14/1986, of April.

In its virtue, on the joint proposal of the Minister of Health, Social Services and Equality and the Minister of Finance and Civil Service, in agreement with the State Council, and after deliberation by the Council of Ministers at its meeting on 9 June 2017,

DISPONGO:

PRELIMINARY TITLE

General provisions

Article 1. Object.

This royal decree is intended to regulate:

a) The ingredients and emissions of tobacco products.

b) Labelling and packaging of tobacco products.

c) The traceability and safety measures of tobacco products.

d) Novel tobacco products.

e) The placing on the market and labelling of certain products related to tobacco products, in particular, devices susceptible to the release of nicotine and recharging containers and herbal products for smoking.

f) The Registry of Manufacturers, Importers and Distributors of Nicotine Release Susceptible Devices and Recharge Containers, the Registry of Manufacturers, Importers, and Herbal Products Distributors for smoking, and the Register of Verification Laboratories.

g) The procedure for the verification and control of tobacco products, the devices susceptible to release of nicotine and herbal products for smoking, as well as the functions and the authorisation procedure of the verification laboratories.

Article 2. Scope.

1. This royal decree shall apply to tobacco products and related products specified in Article 1 (d) which are manufactured or marketed in Spain.

2. This royal decree will not apply to:

(a) Products included in the definition of a medicinal product or medical device to be collected in the recast of the Law on the guarantees and rational use of medicinal products and medical devices approved by the Royal Decree Legislative 1/2015 of 24 July.

(b) Nicotine-releasing devices and recharging packages which are subject to authorisation under the provisions of Royal Decree 1345/2007 of 11 October 2007 governing the procedure for the release of the authorisation, registration and conditions for the supply of medicinal products for human use manufactured industrially, or in Royal Decree 1591/2009 of 16 October 2009 governing medical devices.

Article 3. Definitions.

For the purposes of this royal decree, the following definitions shall apply:

(a) "Additive" means a substance, other than tobacco leaves, added to a tobacco product, its packaging unit or any outer packaging.

(b) "Health warning": warning of adverse effects on human health of products, or other unintended consequences of their consumption, including warnings of text, health warnings combined, general warnings and informational messages.

c) "Combined health warning": a health warning set out in this royal decree, in which a text warning is combined with the corresponding photograph or illustration.

d) "Renting": the anhydrous and nicotine-free raw smoke condensate.

e) "characteristic Aroma" means a clearly discernible smell or taste other than that of tobacco, due to an additive or a combination of additives, including fruits, spices, herbs, alcohol, caramel, menthol or vanilla among others, perceptible before consumption of the tobacco product, or during such consumption.

f) "Flavouring": an additive that confers odor and/or taste.

g) "Substantial change of circumstances": an increase of at least 10% of the sales volume per product category in at least five European Union Member States on the basis of the sales data transmitted in accordance with Article 11.1 or an increase in the level of prevalence in the group of consumers under 25 years of age, of at least five percentage points in at least five Member States, for the category of product concerned. It is not considered that there has been a substantial change of circumstances if the sales volume per category of retail product does not exceed 2,5% of the total sales of tobacco products at the level of the European Union.

(h) 'Cigarette' means a roll of tobacco which can be consumed by a combustion process, the detailed definition of which is laid down in Article 59 (3) and (6) of Law 38/1992 of 28 December 1992. Special.

i) "Cigarrito": a small cigar whose detailed definition is included in paragraphs 1 and 2 of Article 59 of Law 38/1992 of 28 December.

(j) "pure cigar" means a roll of tobacco which can be consumed by a combustion process, the detailed definition of which is laid down in Article 59 (1) and (2) of Law 38/1992 of 28 December 1992.

k) "trade" means an activity which consists of placing products, irrespective of their place of manufacture, at the disposal of consumers, by payment or by payment of such products, including by distance selling.

l) "Consumer" means any natural person acting for purposes other than their business, business, occupational or professional activities.

m) "Nicotine-Releasing Device" means a product, or any of its components, including a cartridge, a tank and the device without a cartridge or a tank, which can be used for the consumption of steam contain nicotine through a mouthpiece. Nicotine release susceptible devices may be disposable or rechargeable by a refill container and a reservoir, or rechargeable with single-use cartridges.

n) "Distribute": an activity that is part of a product's supply chain and consists of its marketing from the manufacturer or importer to the retail establishment.

n) "Outer packaging" means any packaging used to market tobacco products or related products and which includes a packaging unit or a set of packaging units. Transparent wrappers are not considered as outer packaging.

(o) "Emissions" means all substances released when the tobacco product is given, or related to it, the use for which it is intended, such as, for example, substances present in smoke or substances released during the process of consumption of tobacco products without combustion.

p) "Recharge Pack": a liquid receptacle containing nicotine, which can be used to recharge a nicotine-releasing device.

q) "Retail establishment": any establishment in which tobacco products are marketed, including by a natural person.

r) "Manufacturer" means any natural or legal person who manufactures a product, or who orders to design or manufacture a product and markets it under its name or trademark.

s) "Import of tobacco or related products" means the entry into the territory of the European Union of such products, unless they, at the time of their entry into the Union, are included in a customs procedure or procedure suspensory, as well as its release for consumption on the basis of a suspension customs procedure or procedure.

t) "Importer of tobacco or related products" shall mean the owner or the person with the right of disposal of the tobacco and related products which have been introduced into the territory of the Union.

(u) "Ingredients": tobacco, an additive, as well as any substance or element present in the product, including paper, filter, inks, capsules and adhesive rubber.

v) "Nicotine": nicotinic alkaloids.

w) "Maximum level" or "maximum emission level": the maximum content or maximum emission of a substance in a tobacco product, in milligrams, including a value equal to zero.

x) "Petaca": a bite-to-liar packaging unit, either in the form of a rectangular bag with a flap covering the opening or in the form of a stable base petaca.

and) "Picking for the Liar": a smoking tobacco product that meets the requirements set out in Article 59.5 of Law 38/1992, of December 28.

z) "addictive power": the pharmacological potential of a substance to cause addiction, a state that affects the individual's ability to control behavior, generally offering a reward or relief from the withdrawal symptoms, or both.

aa) "Portal EU-CEG" means a common electronic entry portal for all Member States of the European Union in which the communication on tobacco products and related products by manufacturers is carried out; importers.

ab) "A herbal product for smoking": a plant, herbal or fruit product that does not contain tobacco and can be consumed by a combustion process.

(ac) "Tobacco products" means products which may be consumed and constituted, in whole or in part, by tobacco, genetically modified or not.

ad) "Novel tobacco product": tobacco product that:

1, No. It is not included in any of the following categories: cigarettes, liar bite, pipe tobacco, water pipe tobacco, cigars, cigarillos, chewing tobacco, nasal tobacco or oral tobacco; and

2. º Has been marketed after May 19, 2014.

ae) "Smoking tobacco products": tobacco products other than non-combustion tobacco products.

af) "Non-combustion tobacco product" means a tobacco product that does not involve a combustion process, including chewing tobacco, nasal tobacco and oral tobacco.

ag) "Tobacco" means leaves and other natural parts, whether or not processed, of the tobacco plant, including expanded and reconstituted tobacco.

ah) "chewing tobacco": tobacco product without combustion, exclusively for chewing.

ai) "pipe tobacco": tobacco that can be consumed by a combustion process and intended exclusively for use in a pipe.

aj) "nasal use tobacco": a non-combustion tobacco product, which can be administered through the nose.

(ak) "Tobacco for oral use" means all products intended for oral use, with the exception of products for inhaling or chewing, consisting wholly or partly of tobacco in the form of powder, of fine particles or in any combination of these forms, in particular those presented in dose sachets or in porous envelopes.

(a) "water pipe tobacco" means a tobacco product that can be consumed by a water pipe. For the purposes of this royal decree, water pipe tobacco is considered a smoking tobacco product. In case a product can be used as both water pipe tobacco as well as for liar bite quality, it shall be considered to be a liar bite.

(am) "Toxicity" means the extent to which a substance can cause harmful effects in the human body, including long-term effects, usually derived from continuous consumption or exposure.

an) "Packaging unit" means the smallest individual packaging of a product of the tobacco or related product marketed.

TITLE I

Tobacco products

CHAPTER I

Ingredients and Emissions

Article 4. Emissions regime.

1. Cigarettes placed on the market or manufactured in Spain may not have emission levels higher than:

a) 10 mg tar per cigarette.

b) 1 mg nicotine per cigarette.

c) 10 mg of carbon monoxide per cigarette.

2. The emissions of tar, nicotine and carbon monoxide referred to in the previous paragraph shall be measured according to ISO 4387, 10315 and 8454 respectively. The accuracy of the measurement shall be verified in accordance with the provisions of ISO 8243.

Article 5. Regime of ingredients and additives.

1. Tobacco products placed on the market in Spain may not:

a) Having characteristic aroma.

(b) Contain flavourings in their components, such as filters, smoking papers, packaging, capsules, or any other technical characteristic that allows to modify the smell or taste of tobacco products, or to intensify the smoke. Filters, papers and capsules may not contain tobacco or nicotine.

c) Contain any of the following additives:

1. º Vitamins and other additives that create the impression that a tobacco product reports health benefits or reduces the risks to health.

2. º Cafein, taurine or other additives and stimulant compounds associated with energy and vitality.

3. Additives with colorant properties during combustion.

4. Additives to facilitate inhalation or nicotine intake, in the case of tobacco products for smoking.

5. Additives having carcinogenic, mutagenic or reprotoxic properties, hereinafter referred to as CMR, without combustion.

(d) Contain additives in quantities that, on the basis of scientific data, increase significantly and measurably during consumption, the toxic or addictive effect or the CMR properties of a tobacco product.

2. Except as provided for in subparagraph (a) of the previous paragraph, additives essential for the manufacture of tobacco products, such as added sugar to replace sugar which is lost during the curing process, provided that these additives are additives do not give rise to a product with characteristic aroma and do not increase in a significant and measurable way the addictive power, toxicity or CMR properties of the product.

3. The provisions of paragraphs (a) and (b) of the first subparagraph shall not apply to tobacco products other than cigarettes and to the bite for the liar.

4. The procedure applicable for the determination of the characteristic flavourings referred to in paragraph 1.a shall be that provided for in Commission Implementing Regulation (EU) 2016/779 of 18 May 2016 laying down uniform rules concerning the procedures for determining whether a tobacco product has a characteristic flavour and in Commission Implementing Decision (EU) 2016/786 of 18 May 2016 adopting the procedure for the establishment and the operation of an independent advisory group to assist the Member States and the Commission determine whether tobacco products have a characteristic aroma.

5. In the case of products of characteristic flavouring whose sales at European Union level represent 3% or more of a particular product category, the provisions of this Article shall apply from 20 May 2020.

6. The Directorate-General for Public Health, Quality and Innovation shall communicate to the European Commission the measures taken to comply with this Article.

Article 6. Communication obligations in relation to ingredients and emissions.

1. Manufacturers or importers of tobacco products shall submit to the Directorate-General for Public Health, Quality and Innovation within the time limit referred to in Article 7, the following information, detailed by individual marks and types of products:

(a) The list of ingredients, and their quantities, used in the manufacture of tobacco products, ordered by weight decreasing order, as well as their situation. It shall be specified whether the ingredients have been registered in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 and their classification under Royal Decree 255/2003 of 28 February 2006, the Regulation on the classification, packaging and labelling of dangerous preparations, and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and on the labelling of dangerous preparations mixtures, and amending and repealing Directives 67 /548/EEC and 1999 /45/EC and amending the Regulation (EC) No 1907/2006.

(b) A statement of reasons for the inclusion of the ingredients in the tobacco product in question.

(c) Toxicological Data of the ingredients, with or without combustion, and in particular information of its effects on the health of consumers and potential addictive effects.

(d) In the case of cigarettes and the bite to liar, a technical document containing a general description of the additives used and their properties.

e) The emission levels specified in Article 4.

f) Information available on other issues, their levels and measurement methods.

2. Manufacturers or importers shall also be required to communicate any changes affecting the information referred to in the previous paragraph, each time they occur.

3. The Directorate-General for Public Health, Quality and Innovation shall verify that the documentation provided is in accordance with the above paragraphs, and may require the remission of data not provided until it is complete.

4. The communications provided for in this Article shall be carried out through the EU-CEG Portal, in accordance with the provisions of Commission Implementing Decision (EU) 2015/2186 of 25 November 2015 establishing a format for the presentation and making available of information on tobacco products.

Article 7. Deadline for communication.

1. The communication referred to in the previous Article shall be made six months before the date of marketing, in the case of new or modified tobacco products.

2. For tobacco products placed on the market for the entry into force of this royal decree, this communication shall be made within a period of six months from the date of entry into force of this decree, unless such communication has already been made. without prejudice to the fact that the same must be completed in the terms set out in the previous article, or that it is amended, and must be notified in both cases through the EU-CEG Portal.

Article 8. Additional studies on additives.

1. Manufacturers or importers of cigarettes and of the bite to liar containing an additive included in Commission Implementing Decision (EU) 2016/787 of 18 May 2016 establishing a priority list of additives contained in cigarettes and tobacco for the liar subject to reinforced notification obligations, shall carry out exhaustive studies where, for each additive, it is examined whether:

a) Contribute to the toxicity or addictive power of the products in question, and if this results in a significant or measurable increase in the toxicity or addictiveness of any of the products in question.

b) Genera a characteristic aroma.

c) Facilitates inhalation or nicotine intake.

d) Lead to the formation of substances having CMR properties, and in what amounts, and whether it has the consequence that CMR properties are significantly or measurably increased in any of the products that treat.

2. The studies shall take into account the intended use of the products and shall also evaluate:

(a) The emissions resulting from the combustion process in which the additive concerned is involved.

b) The interaction with other ingredients contained in the products concerned.

3. Manufacturers or importers using the same additive in their tobacco products may carry out a joint study when using that additive in the composition of comparable products.

4. Except for the obligations laid down in this Article, small and medium-sized enterprises as defined in Commission Recommendation 2003 /361/EC of 6 May 2003, when another manufacturer or importer produces a report on the additive, be treated.

Article 9. Report of studies on additives.

1. On an annual basis, manufacturers and importers of cigarettes and mints for the liar shall draw up a report which shall contain the results of the studies referred to in the previous Article, and shall have the following content:

a) A summary of the studies done.

b) A detailed presentation that collects the available scientific literature on each additive, and summarizes the internal data on its effects.

2. This report shall be forwarded to the Directorate-General for Public Health, Quality and Innovation and to the European Commission within the time limit laid down in Commission Implementing Decision (EU) 2016/787 of 18 May 2016.

3. The Directorate-General for Public Health, Quality and Innovation shall verify the data in those reports and may request the manufacturer or importer to provide further information on the additive in question, which shall be included in the same report.

4. Where there are reasonable doubts about the studies or results provided in the reports, the Directorate-General for Public Health, Quality and Innovation, the European Commission or any Member State may require that they be reviewed. peer-to-peer in charge of an independent scientific body, in particular with regard to its completeness, methodology and conclusions, in accordance with Implementing Decision (EU) 2016/787 of 18 May 2016.

5. Except for the obligations laid down in this Article, small and medium-sized enterprises as defined in Commission Recommendation 2003 /361/EC of 6 May 2003, when another manufacturer or importer produces a report on the additive, be treated.

Article 10. Information available to the public.

1. The information submitted in accordance with Article 6 (1) and (2) and in Article 8 (1) and (2) shall be available on the website of the Ministry of Health, Social Services and Equality, subject to the following limitations: provided for in the current legislation.

2. From the information referred to in the previous paragraph, manufacturers or importers shall be obliged to specify the information they consider to be subject to commercial secrecy in order to take the necessary measures for their protection.

Article 11. Obligations for the presentation of market studies.

1. Manufacturers or importers of tobacco products placed on the market in Spain shall submit:

(a) The internal and external studies of market research and preferences of different consumer groups, including young people and current smokers, in relation to ingredients and emissions.

(b) The operational summaries of any market research carried out on the basis of the launch of new products.

c) Sales volume information, specified by individual brands and types, in rolls or in kilograms, on an annual basis.

2. This information shall be communicated to the Directorate-General for Public Health, Quality and Innovation in accordance with the format laid down in Commission Implementing Decision (EU) 2015/2186 of 25 November 2015. The first communication will take place within six months of the entry into force of this royal decree and will be presented annually in the first quarter of each year.

CHAPTER II

Labeling and Packaging

Article 12. General provisions on health warnings.

1. Each unit of packaging and the outer packaging of tobacco products shall include in Spanish the health warnings referred to in this Chapter.

2. The health warnings shall be surrounded by a black border of 1 mm wide inside the area reserved for the warning, except in the case of the health warnings referred to in Article 17.

3. The images of the packaging units and the outer packaging shall be in accordance with the provisions of this Chapter.

Article 13. Calculation of the dimensions of health warnings.

1. The dimensions to be taken by the health warnings referred to in this Chapter shall be calculated in relation to the entire area, when the package is closed.

2. Health warnings shall cover the whole area of the packaging unit or packaging which has been reserved for them, and shall not be subject to comment, paraphrase or reference of any other type.

Article 14. Characteristics of the printing of health warnings.

1. The health warnings of the packaging unit and the outer packaging shall be printed in an unmovable and indelible manner and shall be fully visible. They shall not be partially or completely concealed or separated by fiscal stamps, security measures, wrappers, bags, boxes or any other object, mark or legend to be shown.

2. The health warnings must not be separated when the packaging unit is opened, except in the case of packages with a collapsible closure where, in any case, the graphic integrity, the visibility of the text, the photographs and the information on smoking cessation.

3. Health warnings shall not in any case conceal or conceal the tax stamps, the marks for tracking and tracing or the security measures of the packaging units.

4. The health warnings of the packaging units of tobacco products other than cigarettes and of the bite to liar in peels may be affixed by adhesives, provided that they cannot be taken off.

Article 15. General warning and informational message of smoking tobacco products.

1. The packaging units and outer packaging of smoking tobacco products will include the general warning "Smoking kills".

2. In addition, the packaging units and the outer packaging of smoking tobacco products will include the information message "Tobacco smoke contains more than 70 carcinogenic substances".

3. For its location, the following shall be taken into account:

(a) In the cigarette packets and in the cut-off packages for liar in the form of a parallelepiped, the general warning shall be printed at the bottom of the side surface of the packaging unit, and the message information shall be printed at the bottom of the other side surface. These warnings shall be at least 20 mm wide.

b) In packages in the form of an articulated upper body box in which the side surface is divided into two parts when the package is opened, the general warning and the information message shall be printed in full in the largest area of these two surfaces. The general warning shall also appear on the inside surface of the cover which is visible when the box is opened. The side face of this type of package will be at least 16 millimeters high.

c) In the bite to lie in petaca, the health warning and the information message shall be printed on the surfaces that allow full visibility of the health warnings.

d) In the cylindrical-shaped liar-bite packages, the general warning shall be printed on the outer surface of the lid and the information message on the inner surface of the lid.

4. The general warning and information message must:

a) Cover 50% of the surface on which they are printed.

b) Be printed in bold, in Helvetic typographical characters, black on white background, with a font size of the characters that allows to occupy as much space as possible on the surface reserved for the effect.

c) Be centered in the space reserved for printing. In packages in the form of a parallelepiped, and in any outer packaging, they shall be parallel to the side edge of the packaging unit.

5. Except as provided for in the previous paragraph, the sting for liar in petaca, for which the European Commission will establish the exact position of the general warning and the information message.

Article 16. Combined health warnings for smoking tobacco products.

1. Each packaging unit and the outer packaging of smoking tobacco products shall include combined health warnings.

2. The combined health warnings:

(a) They shall be one of the text warnings listed in Annex I and the corresponding colour photograph specified in the Image Library of Annex II.

(b) Include information on smoking cessation, such as telephone numbers, e-mail addresses or Internet sites, the aim of which is to inform consumers of existing programmes to help them. people who want to quit smoking.

c) Cover 65% of the outer face of the front and rear surfaces of the packaging unit, as well as of any outer packaging. The cylindrical-shaped packages shall present two combined health warnings in a manner equidistant from each other and covering 65% of their respective half of the curved surface.

d) Display identical text warnings and color photographs on both sides of the packaging units and all outer packaging.

e) They shall be located on the top edge of the packaging unit or of any outer packaging, and shall appear in the same direction as other information appearing on the packaging surface.

(f) They shall be reproduced in accordance with the format, presentation, design and proportions specified by the Commission, as detailed in Commission Implementing Decisions (EU) 2015/1735 of 24 September 2015 on the exact position of the general warning and the information message in the tobacco for liar in petaca, and Commission Implementing Decision (EU) 2015/1842 of 9 October 2015 on the technical specifications for the presentation, the design and the form of the combined health warnings for smoking tobacco products.

g) Respect, in the packaging units of cigarettes, the following dimensions:

1. Height: not less than 44 mm.

2. th Width: not less than 52 mm.

3. The combined health warnings shall be grouped in three sets, in accordance with the form set out in Annex II. Each game may be used during a calendar year, starting from the entry into force of this royal decree, and will be alternated in such a way as to ensure the regular occurrence of each warning in an equal quantity of packaging units. each brand.

Article 17. Labelling of tobacco products for smoking, other than cigarettes, for lyar and for water-pipe tobacco.

1. Tobacco products for smoking other than cigarettes, for lyar and for water-pipe tobacco shall be exempt from the obligation to include the information message referred to in Article 15.2 and the colour photographs specified in the library of images in Annex II, which are part of the combined health warnings referred to in Article 16.

2. Each packaging unit and the outer packaging of these products shall bear the general warning specified in Article 15.1, which shall meet the following requirements:

(a) Include a reference to the smoking cessation services referred to in Article 16.2.b).

b) Appear on the most visible face of the packaging unit, as well as on any outer packaging, and cover 30% of the outer face of the corresponding surface of the packaging unit and of any outer packaging. If it is to appear on a surface greater than 150 cm², the warning shall cover an area of 45 cm².

c) Meet the requirements specified in paragraphs (b) and (c) of Article 15.4.

d) The text must be parallel to the main text on the surface reserved for those warnings.

e) The general warning shall be surrounded by a black edge of not less than 3 mm and not more than 4 mm wide. This border will appear outside the surface reserved for the general warning.

3. In addition, each packaging unit and the outer packaging of these products shall bear one of the text warnings referred to in Annex I, which:

a) It will be printed on the next most visible surface of the packaging unit, as well as on any outer packaging.

In the articulated packing units, the next most visible surface will be the one that is visible when the box is opened.

(b) Cover 40% of the outer face of the corresponding surface of the packaging unit and of any outer packaging. If it is to appear on a surface greater than 150 cm², the warning shall cover an area of 45 cm².

c) Ira surrounded by a black border of not less than 3 mm and not more than 4 mm wide. This border will appear outside the area reserved for health warnings.

The text warnings referred to in this paragraph shall be alternated in such a way as to ensure the regular occurrence of each warning in an equal quantity of packaging units for each brand.

Article 18. Labelling of tobacco products without combustion.

1. The following health warning shall be included in the packaging units and the outer packaging of the products of the non-combustion tobacco: "This tobacco product is harmful to its health and creates addiction".

2. This health warning:

a) Meet the requirements specified in paragraphs (b) and (c) of Article 15.4.

b) The text must be parallel to the main text on the surface reserved for those warnings.

c) Will appear on the two largest surfaces of the packaging unit, as well as on all outer packaging.

d) Cover 30% of the outer face of the corresponding surface in the packaging unit and in any outer packaging.

Article 19. Presentation of tobacco products.

1. The labelling of each packaging unit, the outer packaging and the tobacco product itself must be written in Spanish. It will not include any elements or features that:

a) Promote a tobacco product or encourage its consumption by making a wrong impression about its characteristics, its effects on health, its dangers or its emissions. It will also not include any information on nicotine, tar or carbon monoxide content.

b) Suggests that a particular tobacco product is less harmful than another, or that it aims to reduce the effect of some harmful components of smoke, or that it has vitalizing, energy, healing, rejuvenating effects, natural, ecological, or other positive effects on health or lifestyle.

c) Refer to flavors, odors, flavourings, or other additives, or to the absence of such additives.

d) Look like a food or cosmetic product.

e) Suggests that a particular tobacco product has improved in biodegradability or other environmental advantages.

2. The packaging unit or the outer packaging shall not include indications suggesting economic advantage by the inclusion of printed reduction bonds, offers of discounts, free distribution or two-by-one or similar offers.

3. The packaging unit or the outer packaging shall not contain any elements or features prohibited in accordance with previous paragraphs, such as texts, symbols, names, markings, figurative signs, drawings, photographs or other similar elements.

Article 20. Aspect and contents of the packaging units.

1. The cigarette packaging units shall be of a parallelepiped form. The tobacco packaging units for the liar shall have a parallelepiped or cylindrical shape or shall have a form of petaca. A cigarette packaging unit shall include at least 20 cigarettes. A tobacco packaging unit for the liar shall contain tobacco with a minimum weight of 30 g.

2. Cigarette packaging units may be made of cardboard or a flexible material and shall not include any openings that may be closed or sealed once again, other than the abatable closure and the articulated upper closure. In the case of the collapsible and hinged closure packs, the closure shall be articulated only by the rear of the package.

Article 21. Traceability of tobacco products.

1. All packaging units for tobacco products shall be marked with a unique identifier. In order to ensure their integrity, the unique identifiers shall be printed in an unmovable and indelible form and must not in any case be disguised or separated, either by tax stamps and price tags, or by the opening of the packaging unit. As regards products manufactured outside the European Union, the obligations laid down in this Article are applicable only to those intended for the European Union market or placed on the market in that market.

2. The unique identifier will allow you to determine the following:

a) The date and place of manufacture.

b) Manufacturing facilities.

c) The machine used to manufacture tobacco products.

d) The production shift or manufacturing time.

e) The product description.

f) The market or retail establishment to which it is intended.

g) The intended shipping path.

h) Where appropriate, the importer in the Union.

i) The effective shipping route, from manufacturing to the first retail establishment, including all warehouses, as well as the ship date, destination, starting point, and recipient.

j) The identity of all buyers, from manufacturing to the first retail establishment.

k) Bills, albarans, and payment vouchers from all buyers, from manufacturing to retail.

3. The information in paragraphs (a), (b), (c), (d), (e), (f), (g) and (h) of the preceding paragraph shall be part of the unique identifier.

4. The information referred to in paragraphs (i), (j) and (k) of paragraph 2 shall be accessible by a link to the unique identifier.

5. All economic operators involved in the trade in tobacco products, from the manufacturer to the last economic operator prior to the first retail establishment, must register the entry of all the packaging units of the which they have, as well as all the intermediate movements and the moment when they definitely cease to dispose of them. This obligation may be fulfilled by marking and recording the packaging of multiple units, such as cardboard, box or pallet, provided that monitoring and tracing of all packaging units is still possible.

6. All natural or legal persons involved in the supply chain for tobacco products shall maintain a complete and accurate record of all relevant transactions referred to in this Article.

7. Manufacturers of tobacco products shall provide all economic operators involved in the trade in tobacco products from the manufacturer to the last economic operator before the first retail establishment, including importers, warehouses and carriers, the equipment necessary to register tobacco products purchased, sold, stored, transported or otherwise handled. The equipment shall be able to read and transmit the data electronically to a data storage facility in accordance with paragraph 8.

8. Manufacturers and importers of tobacco products should enter into data storage contracts with an independent third party in order to host the facility for the storage of all relevant data. The data storage facility shall be physically located within the territory of the European Union. The European Commission shall approve the suitability of the third party, in particular its independence and technical capabilities, as well as the contract.

The activities of that third party will be supervised by an external auditor, proposed and paid by the tobacco product manufacturer and approved by the European Commission. The external auditor shall submit to the competent authorities designated by the Minister of Finance and the European Commission an annual report in which, in particular, he shall assess any irregularities in access.

Data storage facilities shall be fully accessible to the competent authorities of the Member States, the European Commission and the independent external auditor. In duly justified cases, manufacturers or importers may be granted access to the stored data, without prejudice to the fact that the sensitive information from a commercial point of view remains adequately protected, in accordance with the law of the Union and applicable Spanish.

9. No economic operator involved in the trade in tobacco products may amend or delete the registered data.

10. The traceability of tobacco products shall be the responsibility of the Ministry of Finance and the Civil Service, and the rules for the development and implementation of the measures necessary to ensure their compliance shall be governed by Ministerial Order.

11. Personal information shall only be used in accordance with the rules and safeguards laid down in Organic Law 15/1999 of 13 December on the Protection of Personal Data.

12. The above paragraphs shall apply to cigarettes and to the bite to liar from 20 May 2019 and to tobacco products other than cigarettes and the bite to liar from 20 May 2024.

13. It shall be for the Ministry of Finance and Civil Service to lay down the technical standards for the development and implementation of the traceability of tobacco products.

Article 22. Safety measure for tobacco products.

1. In addition to the unique identifier referred to in Article 21, the packaging units of tobacco products placed on the market in Spain shall, in a visible and invisible manner, incorporate a tamper-proof safety measure. The security measure shall be printed or placed in an immovable manner, be indelible and shall not in any case be concealed or concealed, either by tax marks, price tags, or other mandatory elements in accordance with the rules in effect.

Regulated tax marks may be used in the rules of excise duty as a security measure under the conditions that are to be determined.

2. It shall be for the Ministry of Finance and the Civil Service to lay down the technical implementing and implementing rules for the safety measure.

3. Paragraph 1 shall apply to cigarettes and to the sting for the liar from 20 May 2019 and to the tobacco products other than cigarettes and the bite to liar from 20 May 2024.

CHAPTER III

Novel tobacco products and oral tobacco products

Article 23. Communication obligations in relation to novel tobacco products.

1. Manufacturers or importers who intend to market a novel tobacco product shall communicate to the Directorate-General for Public Health, Quality and Innovation through the EU-CEG Portal and in accordance with the format laid down in the Decision. Commission Implementing Regulation (EU) 2015/2186 of 25 November 2015 on the following information

(a) A detailed description of the product of the novel tobacco concerned.

b) A description of the instructions for use.

(c) Information on the ingredients and emissions referred to in Article 6.

2. The above communication must be attached to the following documentation:

a) Scientific studies available on toxicity, addictive and attractive power of the novel tobacco product, in particular as regards its ingredients and emissions.

b) The available studies, as well as summaries thereof, and market research on preferences from different consumer groups, including young people.

(c) Other relevant available information, including a risk/benefit analysis of the product, the expected effects on smoking cessation and the expected effects on the initiation of tobacco consumption, as well as effects on the perceived consumers ' perception.

3. The communication referred to in the preceding paragraphs shall be made six months before the date of the intended marketing of the product.

4. Any modification of the information referred to in the preceding paragraphs shall also be communicated.

5. The Directorate-General for Public Health, Quality and Innovation shall verify that the documentation provided is in accordance with paragraphs 1 and 2, and may require the remission of data not provided until the documentation has been completed. It may also request, in a reasoned manner, manufacturers or importers to carry out additional tests or to submit additional information.

Article 24. Regime applicable to novel tobacco products.

1. In addition to the novel tobacco products which are included in the definition of non-combustion tobacco products provided for in Article 3 (af), it shall also apply to such products as laid down in this royal decree for such products.

2. For novel tobacco products which are included in the definition of smoking tobacco products as provided for in Article 3.ae), it shall also apply to them as laid down in this royal decree for such products.

Article 25. Tobacco for oral use.

The marketing of oral tobacco is prohibited.

TITLE II

Nicotine-releasing devices and refill containers

CHAPTER I

Marketing provisions

Article 26. Communication obligations relating to the placing on the market.

1. Manufacturers or importers intending to market devices susceptible to release of nicotine or recharging packages shall communicate to the Directorate-General for Public Health, Quality and Innovation through the EU-CEG Portal and following the the format laid down in Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and recharging packages, the following information:

(a) Name and contact details of the manufacturer, and, where applicable, of the importer in the European Union.

(b) The description of the composition of the product, including where appropriate the mechanism for opening and reloading the device, or for recharging containers.

(c) The list of all ingredients of the nicotine release susceptible device or the ingredients of the refill package, and the emissions generated by the use thereof, specified by brands and types, including quantities of such ingredients.

(d) toxicological data on ingredients and emissions of the product, even subject to heating, including, in particular, their effects on the health of consumers and taking into account, inter alia, their possible addictive effect.

e) Information about the dosage and intake of nicotine in normal or reasonably foreseeable consumption conditions.

(f) The description of the production process, including serial production, and the declaration that the production process ensures compliance with the requirements of this Article.

g) A statement that the manufacturer and the importer are fully responsible for the quality and safety of the product, once marketed and under normal or reasonably foreseeable conditions of use.

This communication should also be presented when any substantial modification of the devices susceptible to release of nicotine and recharging containers placed on the market occurs.

2. In addition, manufacturers and importers of devices susceptible to release of nicotine and recharging containers must submit to the Directorate-General for Public Health, Quality and Innovation, prior to their marketing, the design of the labelling, packaging and information leaflet for each brand and type of product, in order to verify that it complies with the requirements laid down in Article 30.

3. The Directorate-General for Public Health, Quality and Innovation shall verify that the documentation provided is in accordance with paragraphs 1 and 2, and may require the referral of other data to complete this documentation.

4. The communications referred to in paragraphs 1 and 2 shall be carried out:

a) For new or modified devices, six months before the date of their placing on the market.

(b) For devices susceptible to release of nicotine and reloading containers placed on the market prior to the entry into force of this royal decree, the notification shall be submitted within a period of six months from of the entry into force of the Agreement, unless such communication has already been made, without prejudice to the fact that it is to be completed in the terms set out in paragraphs 1 and 2, or amended, and must be notified in both cases through the EU-CEG Portal.

Article 27. Other communication obligations.

1. Manufacturers and importers of devices susceptible to release of nicotine and recharging packages shall submit, on an annual basis within the first quarter of each year, to the Directorate-General for Public Health, Quality and Innovation. next information:

a) General sales volume, by brand, and product type data.

b) Information about the preferences of various consumer groups, including young people, non-smokers and the main types of current users.

c) The mode of selling the products.

d) The summaries of any market studies conducted in respect of the above, in Spanish or in English.

2. It is the responsibility of the Directorate-General for Public Health, Quality and Innovation to assess the evolution of the market for devices susceptible to nicotine release and recharging containers, and their possible use as a means of access to addiction to nicotine or traditional tobacco use, especially among young people and non-smokers.

Article 28. Quality and safety requirements.

1. Devices susceptible to release of nicotine and recharging packages shall meet the following requirements:

(a) that the liquid containing the nicotine is marketed only in recharging containers with a volume of not more than 10 ml, in devices susceptible to release of disposable nicotine or in single-use cartridges; and the volume of the cartridges or tanks is not greater than 2 ml.

b) That the liquid containing the nicotine does not contain more than 20 mg/ml nicotine.

c) That the liquid containing the nicotine does not contain any of the non-permitted additives referred to in Article 5.1.c).

d) That in the manufacture of the liquid containing the nicotine only ingredients of great purity are used, the quality standards of which have been defined by the European pharmacopoeia or similar, and that any substance other than the ingredients referred to in Article 26.1.c) are present only in the residue levels, provided that it is technically unavoidable during manufacture.

e) That, with the exception of nicotine, in the liquid containing the nicotine, only ingredients that are not dangerous to human health, both hot and cold, and whose quality standards are adjusted to the paragraph (d) of this paragraph.

f) To administer the nicotine doses consistently under normal conditions of use.

g) That they are safe for children and impossible to manipulate, that they are protected from breakage and escapes, and that they have a mechanism that allows for a no-escape refilling.

2. In addition, the nicotine-releasing devices must be constantly administered the nicotine doses under normal conditions of use.

Article 29. Obligations relating to the tests.

1. Manufacturers or importers of devices susceptible to release of nicotine and recharging containers, as responsible for ensuring the quality and safety requirements of their products, shall report annually with the following information: information:

a) The qualitative-quantitative results of the ingredients of these products.

b) The size of the sample relative to the production batch size.

c) The analytical procedures used, as well as the validation of them.

2. This report shall be communicated to the Directorate-General for Public Health, Quality and Innovation during the first quarter of the year following its completion.

Article 30. Labelling and packaging.

1. The packaging units and the outer packaging of the devices susceptible to release of nicotine and refill containers shall meet the following requirements:

a) Include a list of all ingredients that contain the product in descending order and an indication of the nicotine content and its administration by dose, the number of manufacturing batch, and a recommendation that keep out of the reach of children.

(b) Not to include elements or characteristics of those referred to in Article 19.1, except as provided for in paragraphs (b) and (d) concerning information on nicotine content and flavourings.

c) Take the following health warning: " This product contains nicotine, a very addictive substance. Non-smoking is not recommended for use ". This warning shall comply with the requirements specified in Article 18.2.

2. In addition, the packaging units and the outer packaging of the devices susceptible to release of nicotine and refill containers shall include a leaflet, written at least in Spanish, with information on:

a) Use and storage, including warning that the product is not recommended for use by young people and non-smokers.

b) The contraindications.

c) Warnings to specific risk groups.

d) Possible side effects.

e) Addiction and toxicity.

(f) The contact details of the manufacturer or importer and of a natural or legal person in the European Union.

Article 31. Information available to the public.

1. The information submitted in accordance with Article 26.1 shall be available on the website of the Ministry of Health, Social Services and Equality, with the exceptions provided for in the legislation in force.

2. From the information referred to in the previous paragraph, manufacturers or importers shall be obliged to specify the information they consider to be subject to commercial secrecy in order to take the necessary measures for their protection.

CHAPTER II

Registry of Manufacturers, Importers and Distributors of Nicotine Release-Susceptible Devices and Recharge Containers

Article 32. Creating the registry.

1. The Registry of Manufacturers, Importers and Distributors of Nicotine Release-susceptible Devices and Recharge Containers is created for the purpose of collecting and ordering information on these and facilitating the exercise of the actions. administrative related to their possible adverse effects.

2. The register shall be of an administrative nature and shall be attached to the Directorate-General for Public Health, Quality and Innovation, which shall be the body responsible for it.

3. By order of the person holding the Ministry of Health, Social Services and Equality, the characteristics and content of the register shall be determined.

Article 33. Operation of the record.

1. The register shall contain the following information relating to manufacturers, importers and distributors of devices susceptible to release of nicotine and recharging packages having their registered office in Spain:

a) Name and contact details of the manufacturer, importer and distributor in Spain.

b) Name and contact details of the legal representative.

(c) Types, brands and models of products marketed, with indication of the product identification reference, "ID", assigned by the EU-CEG Portal.

2. In the case of manufacturers and importers, the incorporation of this information in the register will be carried out by the Directorate-General for Public Health, Quality and Innovation, on the basis of the data provided to the EU-CEG Portal in the context of the reporting obligations referred to in Article 26. In the case of distributors, they shall communicate the information to the Directorate-General for Public Health, Quality and Innovation, which shall incorporate it into the register.

3. The modification and cancellation of the information contained in the register will be carried out by the General Directorate of Public Health, Quality and Innovation in accordance with the regulations governing the registration.

CHAPTER III

Side effects

Article 34. Information collection system.

1. Manufacturers, importers and distributors of devices susceptible to release of nicotine and recharging packages shall have a system of collection of information on the possible adverse effects of the products they manufacture, import or market, with the following minimum content:

a) Information about possible side effects.

b) Information about the safety and danger of your products.

c) Information about the quality of your products.

2. This information will be available to the Directorate-General for Public Health, Quality and Innovation and the competent health authorities for consultation.

Article 35. Obligations related to adverse effects.

1. Manufacturers, importers and distributors of devices liable for release of nicotine and recharging packages shall be required to take the necessary corrective action immediately, including temporary or permanent withdrawal of such devices. products on the market where there are indications that any of these circumstances may occur:

a) That the products are dangerous or unsafe.

b) Incompliance with the quality standards for ingredients and emissions established in this royal decree.

c) That any other obligations established for these products in this royal decree are violated.

2. In the cases provided for in the previous paragraph, manufacturers, importers and distributors of devices capable of releasing nicotine and recharging packages shall be obliged to forward, in detail and within 24 hours from the date of the adoption of the measure, to the Directorate-General for Public Health, Quality and Innovation, the following information:

a) Risk to health and safety.

b) Corrective measures taken.

The Directorate-General for Public Health, Quality and Innovation will forward this information to the autonomous communities and cities of Ceuta and Melilla.

3. In addition, manufacturers, importers and distributors of devices susceptible to release of nicotine and recharging packages shall be obliged to forward the information referred to in the previous paragraph to the supervisory authorities of the the market of the Member States in which the product is available, or is to be, the product.

Article 36. Surveillance and adoption of measures.

1. In accordance with Chapter I of Title II of Law 33/2011 of 4 October, the Ministry of Health, Social Services and Equality, the Autonomous Communities and the cities of Ceuta and Melilla, in the field of their responsibility for the organisation and management of public health surveillance, the surveillance functions on the risks to human health caused by devices susceptible to release of nicotine and recharging packages, and may be adopted any of the measures provided for in Article 54 of Law 33/2011 of 4 October and in Article 26 of the Law 14/1986, of April 25.

2. The measures taken and the data on which they are supported shall be communicated to the European Commission and the competent authorities of the other Member States.

TITLE III

herbal products for smoking

Article 37. Communication obligations.

1. Manufacturers or importers of herbal products for smoking are required to communicate to the Directorate-General for Public Health, Quality and Innovation through the EU-CEG Portal and in accordance with the format laid down in the Decision of Commission Implementing Regulation (EU) 2015/2186 of 25 November 2015 on

following:

a) The list of all ingredients used in the manufacture of the products, specified by brands and types.

b) The quantities of these ingredients.

2. In addition, manufacturers or importers of herbal products for smoking must submit to the Directorate-General for Public Health, Quality and Innovation, prior to their placing on the market, the design of the labelling and packaging for each product. trade mark and type of product, in order to verify that it complies with the requirements laid down in Article 39.

3. The Directorate-General for Public Health, Quality and Innovation shall verify that the documentation provided is in accordance with the above paragraphs, and may require the remission of data not provided until the documentation has been completed.

4. The communications referred to in paragraphs 1 and 2 of this Article shall be made:

(a) For herbal products for new or modified smoking, six months before the date of their placing on the market.

(b) For smoking herbal products already placed on the market prior to the entry into force of this royal decree, the notification shall be submitted within six months of the entry into force of the itself, unless this information has already been communicated via the EU-CEG Portal.

Article 38. Information available to the public.

1. The information submitted in accordance with Article 37.1 shall be available on the website of the Ministry of Health, Social Services and Equality, with the exceptions provided for in the current legislation.

2. From the information referred to in the previous paragraph, manufacturers or importers shall be obliged to specify the information they consider to be subject to commercial secrecy in order to take the necessary measures for their protection.

Article 39. Labelling and packaging.

1. Each packaging unit and the outer packaging of the herbal products for smoking must include the following general warning: "Smoking this product is harmful to your health".

2. The health warning shall be printed on the rear and front outer faces of the packaging unit and on the outer packaging.

3. The health warning shall cover 30% of the outer face of the corresponding surface of each packaging unit and of any outer packaging, and shall:

a) Be printed in bold, in black Helvetic typographical characters on a white background, with a font size of the characters in such a way as to occupy as much space as possible on the surface reserved for the effect.

b) Be centered in the space reserved for printing, and in the packages in the form of parallelepiped and in any outer packaging, parallel to the side edge of the unit of packaging.

4. The packaging units and the outer packaging of the herbal products for smoking shall not include any element or characteristic which:

a) Promote the product or encourage its consumption by making the wrong impression about its characteristics, its effects on health, its dangers or its emissions.

b) Suggests that the product in particular is less harmful than another, or that it aims to reduce the effect of some harmful components of smoke, or that it has vitalizing, energy, healing, rejuvenating, natural effects, environmental or other positive effects on health or lifestyle.

c) Look like a food or cosmetic product.

d) Indicate that the product does not contain additives or flavourings.

Article 40. Registration of Manufacturers, Importers and Distributors of herbal products for smoking.

1. The Registry of Manufacturers, Importers and Distributors of herbal products for smoking is created for the purpose of collecting and ordering information about them.

2. The register shall be of an administrative nature and shall be attached to the Directorate-General for Public Health, Quality and Innovation, which shall be the body responsible for it.

3. By order of the person holding the Ministry of Health, Social Services and Equality, the characteristics and content of the register shall be determined.

Article 41. Operation of the record.

1. The register shall contain the following information relating to manufacturers, importers and distributors of herbal products for smoking which have their registered office in Spain:

a) Name and contact details of the manufacturer, importer and distributor in Spain.

b) Name and contact details of the legal representative.

(c) Types, brands and models of products marketed, with indication of the product identification reference, "ID", assigned by the EU-CEG Portal.

2. In the case of manufacturers and importers, the incorporation of this information in the register will be carried out by the Directorate-General for Public Health, Quality and Innovation, on the basis of the data provided to the EU-CEG Portal in the context of the reporting obligations referred to in Article 37. In the case of distributors, they shall communicate the information to the Directorate-General for Public Health, Quality and Innovation, which shall incorporate it into the register.

3. The modification and cancellation of the information contained in the register will be carried out by the General Directorate of Public Health, Quality and Innovation in accordance with the regulations governing the registration.

TITLE IV

Verification and control

Article 42. Annual verification plan.

1. The Directorate-General for Public Health, Quality and Innovation will approve an annual verification plan for tobacco products, the devices susceptible to release of nicotine and refill containers and herbal products. for smoking in the market, in order to monitor compliance with the requirements relating to ingredients, emissions, quality and safety provided for in the current legislation.

2. This plan shall contain the marks and types of products to be analysed, the number of samples to be taken and the verification laboratories referred to in Article 44 which shall participate in the tests.

3. The monitoring and control laboratory referred to in Article 43 shall be involved in the preparation of this plan.

Article 43. Control and monitoring laboratory.

1. The Center for Research and Quality Control under the Spanish Agency for Consumption, Food Security and Nutrition, will have the consideration of the Laboratory of Control and Supervision, for the purposes of the established in this royal decree.

2. The Control and Monitoring Laboratory shall collaborate with the Directorate-General for Public Health, Quality and Innovation in the authorisation procedure of the verification laboratories provided for in this Title and shall inspect its operation.

3. The Monitoring and Monitoring Laboratory shall annually prepare a report on compliance with the annual verification plan which it shall forward to the Directorate-General for Public Health, Quality and Innovation.

Article 44. Verification laboratories.

1. The verification laboratories shall check for one or more of the following:

(a) Ingredients referred to in Article 6.1.a)

(b) Levels of emissions referred to in Article 6 (e).

(c) Levels of emissions and ingredients referred to in paragraphs (b), (c) and (d) of Article 26.1 and Article 29.

(d) Quality and safety requirements set out in Article 28.

e) Ingredients referred to in Article 37.1.

To do this, they will be able to carry out tests and trials on tobacco products, nicotine-release devices and recharging containers and herbal products for smoking, according to what you establish. their authorisation and the annual verification plan.

2. The verification laboratories shall be authorised by the Directorate-General for Public Health, Quality and Innovation provided that they comply with the requirements referred to in Article 45. The authorisation shall establish its scope for action in relation to tobacco products, the devices susceptible to release of nicotine and recharging packages and the herbal products for smoking which are found in the market.

Article 45. Requirements of the verification laboratories.

Verification labs must meet the following requirements:

(a) Be independent of entities related to the sector subject to verification and do not belong or be directly or indirectly controlled by them.

b) Dispose of the appropriate financial, technological, human and organizational resources to perform the checks they intend to perform.

c) Develop activities in the field of European and international cooperation on tobacco products, nicotine-releasing devices and refill packaging or herbal products for smoking.

(d) Contar with an implanted quality system, which justifies and determines its technical competence to carry out appropriate measurements on tobacco products, nicotine release susceptible devices, and recharge or herbal products for smoking.

e) Ensuring confidentiality in your actions.

Article 46. Start of the authorization procedure.

1. Entities interested in obtaining an authorization as a verification laboratory shall request it from the General Directorate of Public Health, Quality and Innovation, together with the documentation to justify compliance with the requirements. provided for in Article 45.

2. In addition, they must provide the following documentation:

a) Name and contact details of the lab and legal representative.

b) Description of the scope of action for which authorization is requested.

c) Plano installation and description of the equipment.

(d) Information available in relation to the assurance of the quality of the analytical tests carried out for the control of emissions and components of tobacco products, of devices capable of release Nicotine and refill containers or herbal products for smoking.

Article 47. Procedure instruction.

1. The General Subdirectorate for Health Promotion and Epidemiology shall be the body responsible for the instruction of the procedure, with the collaboration of the Control and Monitoring Laboratory referred to in Article 43.

2. The Control and Monitoring Laboratory shall issue a report on compliance with the requirements laid down in Article 45 after verification visits to the requesting entity.

Article 48. Resolution of the procedure.

1. The Directorate-General for Public Health, Quality and Innovation, within six months of the submission of the application, shall dictate and notify resolution granting or denying the authorisation to the requesting entity.

Elapsed this time without the corresponding resolution being dictated and notified, the request may be understood to be estimated.

2. The authorisation shall define the scope of the laboratory's performance in relation to tobacco products, the devices susceptible to release of nicotine and recharging packages or herbal products for smoking.

3. The decision of the Directorate-General for Public Health, Quality and Innovation may be brought before the General Secretariat for Health and Consumer Affairs, within one month, in accordance with the provisions of Articles 121 and 122 of Law 39/2015 of 1 October of the Common Administrative Procedure of Public Administrations.

4. The Directorate-General for Public Health, Quality and Innovation shall register the content of the authorization in the Register of Verification Laboratories, as referred to in Article 50, and shall communicate it to the European Commission, specifying the criteria used for their authorization, as well as the monitoring means applied.

Article 49. Control, revocation and cessation.

1. The Directorate-General for Public Health, Quality and Innovation will verify compliance with the requirements of the authorization. To do this, it may require the collaboration of the Control and Monitoring Laboratory.

2. In the event of non-compliance with the authorisation or the requirements laid down in Article 45, the Directorate-General for Public Health, Quality and Innovation may revoke the authorisation granted, after hearing the person concerned.

3. When the activity of the laboratory is stopped on its own initiative, it must inform the Directorate-General of Public Health, Quality and Innovation, who will give it discharge in the register and communicate it to the Commission. European.

Article 50. Record of Verification Laboratories.

1. The Verification Laboratories Registry is created for the purpose of collecting and ordering information about authorized verification laboratories.

2. The register shall be of an administrative nature and shall be attached to the Directorate-General for Public Health, Quality and Innovation, which shall be the body responsible for it.

3. By order of the person holding the Ministry of Health, Social Services and Equality, the characteristics and content of the register shall be determined.

Additional disposition first. No increase in public spending.

The provisions of this royal decree will not entail an increase in the amount of appropriations, nor of salaries or other personnel expenses. Also, the implementation and maintenance of the records created through this royal decree will be assumed with the personal means currently in the organization, without increase of budget or other allocations. personnel costs.

Additional provision second. Competence in matters of control and inspection.

In accordance with the provisions of Article 5 of Law 13/1998, of 4 May, of the Ordination of the Market of Tabacos and Tax Regulations, it is up to the Commissioner for the Market of Tabacos to carry out inspection and control functions. set out in Articles 4, 5 and 7 and Chapters II and III of Title I of this royal decree.

First transient disposition. Extension of manufacturing and marketing.

1. Notwithstanding the provisions of the single derogation provision, they may continue to be manufactured or released for free circulation up to three months after the entry into force of this royal decree:

(a) Tobacco products labelled in accordance with the provisions of Royal Decree 1079/2002 of 18 October 2002.

(b) Nicotine-releasing devices and recharging containers and herbal products for smoking, packaged and labelled in accordance with the rules previously in force.

2. The products referred to in the preceding paragraph may continue to be placed on the market for up to 10 months after the entry into force of this royal decree.

3. The sting for the liar in the hooves labelled with a general warning and an information message in accordance with the provisions of Commission Implementing Decision (EU) 2015/1735 may continue to be manufactured or released for free circulation until on 20 May 2018, and continue to be placed on the market until 20 May 2019.

Second transient disposition. Transitional arrangements concerning the position of the combined health warnings.

In the cigarette packaging units to be provided with a circulation pre-tape or other tax mark, with a limit term of 20 May 2019, the position of the combined health warnings shall be governed by the following rules:

(a) If the tax marks are placed on the top edge of a packaging unit made of cardboard, the combined health warnings on the rear surface must be placed directly below the mark. fiscal.

(b) In the case of a flexible material packaging unit, a rectangular surface shall be reserved for the tax marks of a height not exceeding 13 mm between the upper limit of the box and the limit higher than the health warnings.

c) Marks and logos may not be placed above the health warning.

Transitional provision third. Existing verification laboratories at the entry into force of this royal decree.

The laboratories which, at the entry into force of this royal decree, are carrying out some of the functions provided for in Article 44 may continue to perform them for the maximum period of one year from their entry into force although they do not have the authorisation provided for in Title IV of this royal decree.

Single repeal provision. Regulatory repeal.

Royal Decree 1079/2002 of 18 October 2002 regulating the maximum levels of nicotine, tar and carbon monoxide of cigarettes, the labelling of tobacco products and measures is hereby repealed. concerning ingredients and names of tobacco products, and any provisions of equal or lower rank shall be contrary to the provisions of this royal decree.

Final disposition first. Competence title.

This royal decree has the character of a basic rule, dictated by the provisions of article 149.1.16. of the Constitution, which attributes to the State the competence on the basis and general coordination of health.

Final disposition second. Amendment of Decree 2484/1967 of 21 September approving the text of the Spanish Food Code.

Paragraph 3.25.80 of Section 8. of Chapter XXV of Part Three of the Spanish Food Code, approved by Decree 2484/1967 of 21 September, approving the text of the Food Code, is deleted. Spanish.

Final disposition third. Incorporation of European Union law.

1. This royal decree partially incorporates into Spanish law Directive 2014 /40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States of the European Union. Member States in the manufacture, presentation and sale of tobacco products and related products and repealing Directive 2001 /37/EC.

Also incorporated into Spanish law Commission Delegated Directive 2014 /109/EU of 10 October 2014 amending Annex II to Directive 2014 /40/EU of the European Parliament and of the Council establishing the library of graphic warnings to be used for tobacco products.

2. References made in the rules in force to Directive 2001 /37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the the manufacture, presentation and sale of tobacco products shall be construed as references to Directive 2014 /40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of laws, regulations and Member States ' administrative authorities in the field of manufacturing, presentation and sale of the products of tobacco and related products and repealing Directive 2001 /37/EC.

Final disposition fourth. Regulatory enablement.

1. The holder of the Ministry of Health, Social Services and Equality shall be empowered to make any provisions necessary for the development of the provisions laid down in this royal decree with the exception of Articles 21 and 22, in respect of which the holder of the Ministry of Finance and Civil Service is responsible for issuing the technical standards for the development and implementation of the traceability of tobacco products and safety measures.

2. By order of the person holding the Ministry of Health, Social Services and Equality, they may be:

(a) Set maximum emission levels for cigarettes referring to substances other than those referred to in Article 4.

b) Establish the maximum levels of substances emitted by other tobacco products other than cigarettes.

c) Establish the emission measurement methods referred to in the preceding paragraphs.

The Directorate-General for Public Health, Quality and Innovation shall communicate to the European Commission the maximum levels and measurement methods to be established in accordance with this paragraph.

Final disposition fifth. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given at the Embassy of Spain in Astana, on June 9, 2017.

FELIPE R.

The Vice President of the Government and Minister of the Presidency and for Territorial Administrations,

SORAYA SAENZ DE SANTAMARIA ANTON

ANNEX I

List of text warnings

(1) Smoking causes 9 out of 10 lung cancers.

(2) Smoking causes mouth and throat cancer.

(3) Smoking damages the lungs.

(4) Smoking causes infarcts.

(5) Smoking causes embolism and invalidity.

(6) Smoking clogs the arteries.

(7) Smoking increases the risk of blindness.

(8) Smoking damages teeth and gums.

(9) Smoking can kill the waiting child.

(10) Your smoke is bad for your children, family and friends.

(11) Children of smokers are more likely to start smoking.

(12) Stop smoking: stay alive for your loved ones.

(13) Smoking reduces fertility.

(14) Smoking increases the risk of impotence.

ANNEX II

Image Library

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